Lutalyse Sterile: Product Information

LUTALYSE STERILE- dinoprost tromethamine injection, solution
Zoetis Inc.

Caution

Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.

(dinoprost tromethamine injection)

5 mg dinoprost/mL as dinoprost tromethamine

DESCRIPTION

LUTALYSE® Injection (5 mg dinoprost/mL) is a sterile solution containing the naturally occurring prostaglandin F2 alpha (dinoprost) as the tromethamine salt. Each mL contains dinoprost tromethamine equivalent to 5 mg dinoprost: also, benzyl alcohol, 16.5 mg added as preservative and water for injection.

When necessary, pH was adjusted with sodium hydroxide and/or hydrochloric acid. Dinoprost tromethamine is a white or slightly off-white crystalline powder that is readily soluble in water at room temperature in concentrations to at least 200 mg/mL.

INDICATIONS AND USAGE

Cattle

LUTALYSE Injection is indicated as a luteolytic agent. LUTALYSE Injection is effective only in those cattle having a corpus luteum, i.e., those which ovulated at least five days prior to treatment.

Future reproductive performance of animals that are not cycling will be unaffected by injection of LUTALYSE Injection.

• For estrus synchronization in beef cows, beef heifers and replacement dairy heifers

• For unobserved (silent) estrus in lactating dairy cows with a corpus luteum

• For treatment of pyometra (chronic endometritis) in cattle

• For abortion in beef cows, beef heifers and replacement dairy heifers

• For use with FACTREL (gonadorelin injection) Injection to synchronize estrous cycles to allow fixed-time artificial insemination (FTAI) in lactating dairy cows

• For use with EAZI-BREEDTM CIDR® (progesterone intravaginal insert) Cattle Insert for synchronization of estrus in lactating dairy cows

• For use with EAZI-BREEDTM CIDR® (progesterone intravaginal insert) Cattle Insert for synchronization of estrus in suckled beef cows and replacement beef and dairy heifers, advancement of first postpartum estrus in suckled beef cows, and advancement of first pubertal estrus in beef heifers

Swine

• For parturition induction in swine

Mares

• For controlling the timing of estrus in estrous cycling mares

• For difficult-to-breed mares (clinically anestrous mares that have a corpus luteum)

MANAGEMENT CONSIDERATIONS

Many factors contribute to success and failure of reproduction management, and these factors are important also when time of breeding is to be regulated with LUTALYSE Injection. Some of these factors are:

a. Cattle must be ready to breed—they must have a corpus luteum and be healthy;

b. Nutritional status must be adequate as this has a direct effect on conception and the initiation of estrus in heifers or return of estrous cycles in cows following calving;

c. Physical facilities must be adequate to allow cattle handling without being detrimental to the animal;

d. Estrus must be detected accurately if timed Al is not employed;

e. Semen of high fertility must be used;

f. Semen must be inseminated properly.

A successful breeding program can employ LUTALYSE Injection effectively, but a poorly managed breeding program will continue to be poor when LUTALYSE Injection is employed unless other management deficiencies are remedied first. Cattle expressing estrus following LUTALYSE Injection are receptive to breeding by a bull. Using bulls to breed large numbers of cattle in heat following LUTALYSE Injection will require proper management of bulls and cattle.

DOSAGE AND ADMINISTRATION

As with any multi-dose vial, practice aseptic techniques in withdrawing each dose to decrease the possibility of post-injection bacterial infections. Adequately clean and disinfect the vial stopper prior to entry with a sterile needle and syringe. Use only sterile needles, and use each needle only once.

No vial stopper should be entered more than 20 times. For this reason, the 100 mL bottle should only be used for cattle. The 30 mL bottle may be used for cattle, swine, or mares.

Cattle

1. For Estrus Synchronization in Beef Cows, Beef Heifers and Replacement Dairy Heifers. LUTALYSE Injection is used to control the timing of estrus and ovulation in estrous cycling cattle that have a corpus luteum. Inject a dose of 5 mL LUTALYSE Injection (25 mg dinoprost) intramuscularly either once or twice at a 10 to 12 day interval. With the single injection, cattle should be bred at the usual time relative to estrus. With the two injections cattle can be bred after the second injection either at the usual time relative to detected estrus or at about 80 hours after the second injection of LUTALYSE Injection. Estrus is expected to occur 1 to 5 days after injection if a corpus luteum was present. Cattle that do not become pregnant to breeding at estrus on days 1 to 5 after injection will be expected to return to estrus in about 18 to 24 days.

2. For Unobserved (Silent) Estrus in Lactating Dairy Cows with a Corpus Luteum. Inject a dose of 5 mL LUTALYSE Injection (25 mg dinoprost) intramuscularly. Breed cows as they are detected in estrus. If estrus has not been observed by 80 hours after injection, breed at 80 hours. If the cow returns to estrus, breed at the usual time relative to estrus.

3. For Treatment of Pyometra (chronic endometritis) in Cattle. Inject a dose of 5 mL LUTALYSE Injection (25 mg dinoprost) intramuscularly.

4. For Abortion in Beef Cows, Beef Heifers and Replacement Dairy Heifers. LUTALYSE Injection is indicated for its abortifacient effect in beef cows, beef heifers and replacement dairy heifers during the first 100 days of gestation. Inject a dose of 25 mg dinoprost (5 mL) intramuscularly. Cattle that abort will abort within 35 days of injection.

5. For use with FACTREL® (gonadorelin injection) Injection to synchronize estrous cycles to allow fixed-time artificial insemination (FTAI) in lactating dairy cows: Administer 2 to 4 mL FACTREL Injection (100-200 mcg gonadorelin) per cow as an intramuscular injection in a treatment regimen with the following framework:

• Administer the first dose of FACTREL Injection (2-4 mL) at Day 0

• Administer LUTALYSE (25 mg dinoprost, as dinoprost tromethamine) Injection by intramuscular injection 6-8 days after the first dose of FACTREL Injection.

• Administer a second dose of FACTREL Injection (2-4 mL) 30 to 72 hours after the LUTALYSE injection.

• Perform FTAI 0 to 24 hours after the second dose of FACTREL Injection, or inseminate cows on detected estrus using standard herd practices.

Below are three examples of treatment regimens for FTAI that fit within the dosage regimen framework described immediately above:

Example 1 Example 2 Example 3

Day 0

(Monday)

1st FACTREL

1st FACTREL

1st FACTREL

Day 7

(the following Monday

LUTALYSE

LUTALYSE

LUTALYSE

Day 9 (Wednesday)

2nd FACTREL + FTAI at 48 hours after LUTALYSE

2nd FACTREL at 48 hours after LUTALYSE 2nd FACTREL at 56 hours after LUTALYSE

Day 1

(Thursday)

FTAI 24 hours after 2nd FACTREL FTAI 18 hours after 2nd FACTREL

6. For use with EAZI-BREED™ CIDR® (progesterone intravaginal insert) Cattle Insert for Synchronization of Estrus in Lactating Dairy Cows:

• Administer one EAZI-BREED CIDR Cattle Insert per animal and remove 7 days later (for example if administered on a Monday remove the following Monday).

• Administer 5 mL LUTALYSE Injection at the time of removal of the EAZI-BREED CIDR Cattle Insert.

• Observe animals for signs of estrus on Days 2 to 5 after removal of the EAZI-BREED CIDR Cattle Insert and inseminate animals found in estrus following normal herd practices.

7. For use with EAZI-BREED™ CIDR® (progesterone intravaginal insert) Cattle Insert for synchronization of estrus in suckled beef cows and replacement beef and dairy heifers, advancement of first postpartum estrus in suckled beef cows, and advancement of first pubertal estrus in beef heifers:

• Administer one EAZI-BREED CIDR Cattle Insert per animal for 7 days (for example, if administered on a Monday remove on the following Monday).

• Inject 5 mL LUTALYSE Injection (equivalent to 5 mg/mL dinoprost) 1 day prior to EAZIBREED CIDR Cattle Insert removal, on Day 6 of the 7 day administration period.

• Observe animals for signs of estrus on Days 1 to 3 after removal of the EAZI-BREED CIDR Cattle Insert and inseminate animals about 12 hours after onset of estrus.

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